510(k) · Cleared
ClearedFine Grain Cast Cobalt Chromium Hip Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jan 31, 1996 after a 166-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 31, 1996
- Review
- 166 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK953925 Fine Grain Cast Cobalt Chromium Hip StemsBiomet, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK063002 Altra Press-Fit Hip SystemBiomet Manufacturing Corp · 2006
- Descendant · 2 generations on · 2 of its ownK070274 Echo BI-Metric Press-Fit StemsBiomet Manufacturing Corp · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK143009 Echo Bi-Metric Microplasty Hip SystemBiomet, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK150503 Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK030087 Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K063002Altra Press-Fit Hip SystemBiomet Manufacturing Corp · 2006 · cites it directly3descendants
- K070274Echo BI-Metric Press-Fit StemsBiomet Manufacturing Corp · 2007 · 2 generations on2descendants
- K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc. · 2014 · 3 generations on1descendant
- K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc. · 2015 · 4 generations on0descendants
- K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953925 | Fine Grain Cast Cobalt Chromium Hip Stems | Biomet, Inc. | 1996 | — |
| +1 | K063002 | Altra Press-Fit Hip System | Biomet Manufacturing Corp | 2006 | — |
| +2 | K070274 | Echo BI-Metric Press-Fit Stems | Biomet Manufacturing Corp | 2007 | 3 |
| +3 | K143009 | Echo Bi-Metric Microplasty Hip System | Biomet, Inc. | 2014 | — |
| +4 | K150503 | Echo Bi-Metric Microplasty Line Extension | Biomet, Inc. | 2015 | — |
| +1 | K030087 | Spinal Concepts, Inc. Bacfix TI Spinal System | Spinal Concepts, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063002 (Biomet Manufacturing Corp, 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
https://510kreport.com/device/K953925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953925: Fine Grain Cast Cobalt Chromium Hip Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953925
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026